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临床试验/NCT07525011
NCT07525011尚未招募不适用

Comparative Study of Traditional Complete Denture Fabrication Technique and the Easdent Digital Complete Denture Fabrication Technique in a Predoctoral Dental Clinic

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Total Clinical Chair Time per Denture Fabrication Method

研究概览

简要总结

This study is a randomized, single-blinded clinical study conducted in the predoctoral clinic at Rutgers School of Dental Medicine. The purpose of this study is to compare a traditional complete denture fabrication technique with the Easdent digital complete denture workflow. The Easdent technique is a modification of the conventional method and utilizes FDA-approved materials and 3D-printed trays designed to record teeth position, jaw relations and impression information. Participants who require new dual-arch complete dentures will receive dentures fabricated using both techniques. The order of fabrication and delivery will be randomized. Clinical chair time, number of appointments, and total treatment time will be recorded. Patient-reported outcomes will be assessed using a modified OHIP-EDENT survey and preference questions after completion of both dentures. Student participants will also complete surveys evaluating learning experience and clinical usability. The study does not evaluate the safety or effectiveness of a drug or investigational device. All materials used are FDA-cleared and routinely used in clinical practice. The overall aim is to evaluate efficiency, patient satisfaction, and educational usability of the two denture fabrication workflows.

详细描述

Complete dentures remain a common treatment for fully edentulous patients. The traditional complete denture fabrication workflow requires multiple clinical visits, including preliminary impressions, custom tray fabrication, border molding, final impressions, record base and wax rim fabrication, jaw relation records, tooth try-in, and final delivery. This process is technique-sensitive, time-intensive, and may require numerous patient appointments. In predoctoral dental education settings, the complexity of the workflow can also contribute to variability in clinical efficiency and student learning experience. The Easdent digital complete denture workflow is a modification of the conventional technique. It incorporates 3D-printed trays fabricated from FDA-cleared medical-grade denture tray or try-in denture materials. These trays are designed with features similar to try-in dentures, including standardized tooth positioning and idealized intercuspation between maxillary and mandibular arches. Retention holes are incorporated to allow the use of conventional impression materials in a manner similar to traditional stock trays. The trays are produced in multiple standardized sizes to accommodate variation in jaw dimensions. The workflow is intended to streamline the recording of esthetics (such as midline and horizontal reference lines), occlusal vertical dimension, and maxillomandibular relationships while maintaining compatibility with conventional denture processing techniques. This study is designed to compare the traditional complete denture workflow with the Easdent digital complete denture workflow in a predoctoral clinical environment. The investigation focuses on efficiency, patient-reported outcomes, and educational usability rather than safety or effectiveness of a drug or investigational device. All materials used in this study are FDA-cleared and routinely used in standard dental practice. Participants who require new dual-arch complete dentures will receive dentures fabricated using both workflows. The order of fabrication and delivery will be randomized to reduce sequencing bias. The study uses a single-blinded design in which participants are not informed which denture corresponds to which fabrication method at the time of evaluation. After completion and adjustment of both dentures, participants will complete standardized patient-reported surveys and indicate their preference. Clinical efficiency metrics include the number of appointments required, chair time per visit, and total treatment duration associated with each workflow. These data are recorded prospectively by trained student researchers under faculty supervision. Standardization procedures, including calibration sessions and training lectures, are implemented to reduce inter-operator variability. Patient-reported outcomes are assessed using a modified OHIP-EDENT 19 questionnaire, supplemented with additional items evaluating esthetic satisfaction and overall satisfaction. Surveys are administered after an adaptation period following delivery of both dentures to allow patients to assess comfort, function, and esthetics. Preference data are collected after participants have experienced both prostheses. In addition to patient outcomes, the study evaluates the educational impact of the two workflows. Student researchers complete structured surveys assessing perceived learning difficulty, procedural complexity, and overall workflow usability. This component is intended to evaluate feasibility and integration of the modified workflow within a predoctoral dental curriculum. The anticipated risks are consistent with routine complete denture treatment and include temporary mucosal soreness, minor discomfort during impression procedures, temporary speech adaptation, and the potential need for post-insertion adjustments. No additional risks beyond standard denture treatment are introduced by study participation. The study is considered minimal risk. The findings of this study may provide data regarding clinical efficiency, patient-centered outcomes, and educational feasibility of a modified denture fabrication workflow in an academic clinical setting. Results may inform decisions regarding curriculum design and clinical workflow optimization in complete denture therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will not be informed which denture corresponds to the traditional fabrication workflow or the Easdent digital workflow at the time of evaluation. Student providers, supervising faculty, and investigators will be aware of the fabrication method used. No other parties are masked.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Requiring new dual-arch complete dentures.
  • Willing and able to attend for all required study appointments, including delivery and follow-up visits.

排除标准

  • Requiring only single-arch complete dentures.
  • Presence of severe medical conditions that would preclude attendance at multiple prosthodontic appointments.
  • Active, untreated oral mucosal disease that would prevent impression making or denture fabrication.
  • Severely resorbed edentulous ridges.
  • Unable or unwilling to attend for all scheduled study visits or follow-up appointments.
  • Unable to comply with instructions necessary for denture treatment or study procedures.

研究组 & 干预措施

Traditional Complete Denture Fabrication

Experimental

Participants receive complete dentures fabricated using the conventional complete denture workflow.

干预措施: Traditional Complete Denture Fabrication (Procedure)

Easdent Digital Complete Denture Fabrication

Experimental

Participants receive complete dentures fabricated using the Easdent digital complete denture workflow utilizing 3D-printed trays.

干预措施: Easdent Digital Complete Denture Fabrication (Procedure)

结局指标

主要结局

Total Clinical Chair Time per Denture Fabrication Method

时间窗: From initial impression appointment to final denture delivery (approximately 1-4 months)

Total accumulated clinical chair time (in minutes) required to complete denture fabrication for each workflow, measured from initial impression appointment through final delivery and necessary adjustments.

次要结局

  • Patient-Reported Oral Health-Related Quality of Life (Modified Oral Health Impact Profile for Edentulous Adults Score)(From enrollment to the end of treatment, an average of 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Elkassaby, BDS, DMD, MDSc, FACP

Associate Professor

Rutgers, The State University of New Jersey

研究点 (1)

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